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    • Self Extracting File Format
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    • $330.00
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About This Item


Full Description

This product comes with 4 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.

New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!

New and updated checklist for the April, 2000 version of IEC 60601-1-4, "Medical Electrical Equipment - Part I: General Requirements for Safety - Section 4, Collateral Standard: Programmable Electrical Medical Systems".

To reflect the change SEPT has analyzed this new version and added over 100 physical evidence items that enable compliance, (either as required or recommended items). The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This revision clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard. For medical device firms, use of the Checklist will save time and money, and may aid in meeting certain governmental requirements.

The Checklist is a quality product at a reasonable price!